Effects of Hydrocortison Treatment on Angiotensin II and Angiotensin II Receptors in Patients With Septic Shock

NCT ID: NCT04647552

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-02-06

Brief Summary

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This study aims to evaluate the role of angiotensin II, AT1, and AT2 on catecholomine responsive and catecholomine resistant septic shock, and the effect of hydrocortisone traetment on catecholomine resistant septic shock and angiotensin II, AT1, and AT2.Angiotensin II can be used as a biomarker of vasoplegia observed in refractory septic shock unresponsive to catecholamine. In these patients; therapeutic effect of hydrocortisone on hypotension was performed by decreasing AT 2 level, AT2 should be investigated as a therapeutic target in the treatment of vasoplegia-induced hypotension and SVRI measured by minimally invasive cardiac output method suggests that it can be used as a useful parameter in the diagnosis and follow-up of vasoplegia.

Detailed Description

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This study will be enrolled 40 patients diagnosed with septic shock according to Sepsis 3 criteria. The patients with septic shock who needed a noradrenaline infusion rate of up to 0.5µg/kg/min to maintain MAP\>65 mmHg will be classified as control group (n=20) and the ones who required a noradrenaline infusion rate above 0.5µg/kg will be classified as hydrocortisone group (n=20). Blood samples will be taken for analysis of plasma angiotensin II, AT1, AT2 levels at the time of diagnosis, one hour after and on the 3rd day of the bundle and the hydrocortisone treatment. Hemodynamic parameters simultaneously obtain by continuous minimal invasive cardiac output measurement method will record.

Conditions

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Shock, Septic

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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hydrocortisone

The patients with septic shock who required a noradrenaline infusion rate above 0.5µg/kg

Drug Steroid

Intervention Type DRUG

hydrocortisone injection

control

The patients with septic shock who needed a noradrenaline infusion rate of up to 0.5µg/kg/min to maintain MAP\>65 mmHg

No interventions assigned to this group

Interventions

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Drug Steroid

hydrocortisone injection

Intervention Type DRUG

Other Intervention Names

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hydrocortisone

Eligibility Criteria

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Inclusion Criteria

* septic shock patient

Exclusion Criteria

* other causes of end-stage organ failure, immunodeficiency, presence of acute mesenteric ischemia, vasospastic disease, pregnancy, other shock causes (hypovolemic, cardiogenic, neurogenic), life expectancy less than 48 hours corticosteroid use in the last 4 weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Ayse Belin Ozer

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayse Belin B OZER

Role: PRINCIPAL_INVESTIGATOR

Inonu University Faculty of Medicine

Locations

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Ayse Belin B OZER

Malatya, , Turkey (Türkiye)

Site Status

Ayse Belin OZER

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

Reference Type BACKGROUND
PMID: 26903338 (View on PubMed)

Zhang W, Chen X, Huang L, Lu N, Zhou L, Wu G, Chen Y. Severe sepsis: Low expression of the renin-angiotensin system is associated with poor prognosis. Exp Ther Med. 2014 May;7(5):1342-1348. doi: 10.3892/etm.2014.1566. Epub 2014 Feb 20.

Reference Type BACKGROUND
PMID: 24940436 (View on PubMed)

Other Identifiers

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AOzer

Identifier Type: -

Identifier Source: org_study_id

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